Job Overview
At Norgine, we encourage colleagues to be different, drive toward goals, and develop themselves and their community. We call this the 3D career and it offers a fully-rounded experience with no limits. Bring everything about yourself that you’re proud of – whether that’s a passion for making a difference, focus on others’ well‑being, or intellectual curiosity to unleash in a fast‑paced environment. In return, you’ll gain a sense of belonging, a long‑term career with ongoing development and upskilling, and a company that cares about people’s wellness.
We have an exciting opportunity for a Compliance Engineer to join Norgine.
Core Responsibilities
* Ensure that products, systems, and processes adhere to applicable safety, quality, and regulatory standards.
* Conduct inspections, perform tests, and analyse data to identify areas of non‑compliance and implement corrective actions.
* Ensure compliance of the site calibration process and control the Engineering Maintenance Management Systems (EMMS) to keep all planned, unplanned and reactive maintenance events compliant.
* Deputise for the Compliance Team Leader when required.
Requirements
* Carry out calibration works across all relevant machines and processes, investigating and correcting issues.
* Hands‑on fault finding; document and report root cause analysis and countermeasures in line with QMS procedures.
* Manage the EMMS system – review, approve and file Engineering Works Orders in line with approved SOPs.
* Supervise administration support for issuing Engineering Works Orders to schedule.
* Manage the Engineering Task List (ETL) process, ensuring ETLs are compliant at all times.
* Review current SOPs and develop a suite of SOPs to detail the site engineering maintenance strategy in line with EMMS and ISPE guides.
* Support QA and Engineering departments (Site Services & Maintenance Sections) on QMS investigations and countermeasures where required.
* Support QA internal audit schedule by performing internal audits as required.
* Proactive analysis of calibration and maintenance procedures and practices, regular reviews and updates in line with relevant good practice guides and improvement opportunities.
* Develop and introduce risk analysis of current maintenance and calibration methods to reduce or increase tasks to ensure an efficient and compliant system.
* Support QA and Engineering departments on other activities as directed when required.
* Maintain tools and equipment in safe working condition; ensure workshop and plant rooms are safe environments.
* Adhere to technical procedures and good manufacturing processes (GMP).
* Work in a clean, orderly manner in compliance with the company’s hygiene code of practice.
* Ensure all health and safety standards are met and that all equipment complies with company and legal standards.
* Ensure work orders are completed on time.
* Liaise effectively with external contractors.
* Willing to learn new skills (on and off the job) and train others when required.
* Represent the Engineering Department in production meetings and contribute to effective communication.
* Develop and maintain good working relationships with production managers.
* Present a good image of the engineering department, acting professionally and positively at all times.
* Support the company vision, goals and agreed targets.
* Communicate effectively, build and maintain relationships, act decisively, demonstrate resilience and flexibility, and pay attention to detail.
* Drive change, work on own initiative, think systematically, inspire change, and contribute own views.
Key Responsibilities & Accountabilities
* Ensure Health and Safety, Quality and Compliance are maintained to a high standard at all times.
* Respond promptly to emergencies and address any disruptions.
* Monitor performance metrics, detect issues, diagnose faults, and implement corrective actions.
* Support QA and Engineering Departments in compliance activities to meet FDA, MHRA & ISO 13485 medical device requirements.
* Meet expectations of GxP, QMS and site quality standards.
* Oversee and manage all systems involving calibrations, maintenance and document review.
Skills & Knowledge
* Proactive approach to fault finding, commitment to continuous improvement and personal development.
* Knowledge, discipline and initiative to work alone.
* Practical attitude and a team approach to engineering issues.
* Ability to work under pressure and to tight deadlines.
* Effective communication skills (written and verbal).
* Computer literate with working knowledge of MS Office and a PPM system.
* Ability to understand electrical and mechanical drawings/manuals.
* Logical and flexible working approach.
* Sense of urgency – proactive in driving continuous improvement initiatives.
* Excellent decision‑making skills.
Benefits
Benefits vary by location. Please liaise with the Norgine TA representative to obtain more information.
Sound good? Find out more about the career you’ll have with Norgine, then apply here.
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